Rivaroxaban versus high dose nadroparin for thromboprophylaxis after hip or knee arthroplasty

Summary

Deep-vein thrombosis and subsequent pulmonary embolism are major complications in total joint arthroplasty of the lower limbs. New oral anticoagulants are increasingly prescribed as thromboprophylaxis due to their simple administration and encouraging phase III marketing studies.

Patients, methods

In this observational study, we compared the efficacy and safety of rivaroxaban with nadroparin in 1302 unselected patients receiving hip or knee arthroplasty.

Results

Venous thrombembolism occurred in 3.3% (2.3%; 4.7%, 95% CI, n = 838) of patients receiving rivaroxaban and in 4.3% (2.7%; 6.7%, 95% CI, n = 464) of patients receiving nadroparin resulting in an absolute risk reduction (ARR) of 1.0% (–1.4%; 3.3%, 95% CI).

Conclusions

With an odds ratio of 0.6 (0.4; 1.0, 95% CI), rivaroxaban was associated with a decreased perioperative drop in haemoglobin exhibiting an improved thromboprophylactic profile when compared to high dose nadroparin. Furthermore, transfusion rates were 8.8% (−2.7%; 19.9%, 95% CI) lower in patients receiving rivaroxaban. However, as previous studies have shown, low preoperative haemoglobin remains the most predictive factor for postoperative transfusions (OR: 2.4 [1.3; 4.4, 95% CI]).

Zusammenfassung

Tiefe Venenthrombose und in der Folge Lungenembolien sind gefürchtete Komplikationen der endoprothetischen Versorgung der unteren Extremität. Aufgrund der guten Studienlage ihrer Phase III Studien, werden zur Prophylaxe immer mehr auch neue orale Antikoagulanzien verschrieben.

Patienten, Methoden

In dieser Beobachtungsstudie verglichen wir die Effektivität und Sicherheit von Rivaroxaban mit Nadroparin anhand 1302 nicht ausgewählter Patienten, die eine Knieoder Hüft-TEP erhalten hatten.

Ergebnisse

Ein thrombembolisches Ereignis wurde bei 3,3% (2,3%; 4,7%, 95%-KI, n = 838) der Patienten unter Rivaroxaban und bei 4.3% (2,7%; 6,7%, 95%-CI, n = 464) der Patienten unter Nadroparin festgestellt, was eine absolute Risikoreduktion (ARR) von 1,0% (–1,4%; 3,3%, 95%-KI) ergab. Patienten unter Rivaroxaban hatten weiter mit einer Odds-Ratio von 0,6 (0,4; 1,0, 95% KI) einen geringeren perioperativen Hämoglobinabfall.

Schlussfolgerung

Rivaroxaban zeigte im Vergleich zu hoch dosierten Nadroparin ein besseres thromboprophylaktisches Profil. Weiter waren 8,8% (–2.7%; 19,9%, 95%-KI) weniger Bluttransfusionen unter Rivaroxaban zu verzeichnen. Der stärkste prädiktive Faktor für eine postoperative Transfusion blieb, wie in anderen Studien, ein niedriger präoperativer Hämoglobinwert (OR: 2,4 [1,3; 4,4, 95%-CI]).

Keywords

Thrombosis - nadroparin - rivaroxaban

Schlüsselwörter

Venenthrombose - Nadroparin - Rivaroxaban

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